Human vaccinia virus immune globulin

VIGIV (vaccinia immune globulin intravenous, human) is indicated for the treatment and/or modification of the following conditions: • Eczema vaccinatum • Progressive vaccinia • Severe generalized vaccinia • Vaccinia infections in individuals who have skin conditions such as burns, impetigo, varicella-zoster, or poison ivy, or in individuals who have eczematous skin lesions because of either the activity or extensiveness of such lesions • Aberrant infections induced by vaccinia virus that include its accidental implantation in eyes (except in cases of isolated keratitis), mouth, or other areas where vaccinia infection would constitute a special hazard. VIGIV is not considered to be effective in the treatment of postvaccinial encephalitis.

VIGIV provides passive immunity for individuals with complications to vaccinia virus vaccination. The exact mechanism of action is not known.

For intravenous use only. • For intravenous use only. • VIGIV is administered at a dose of 6000 Units per kg, as soon as symptoms for complication(s) due to vaccinia vaccination appear. • Higher doses (e.g. 9000 Units per kg or 24,000 Units per kg) may be considered in the event that the patient does not respond to the initial dose of 6000 Units per kg. • For patients with risk factors for thrombosis, the maximum daily dose of VIGIV should not exceed 12,000 Units per kg.

VIGIV is contraindicated in: • Isolated vaccinia keratitis. • Individuals with a history of anaphylaxis or prior severe systemic reaction associated with the parenteral administration of this or other human immune globulin preparations. • IgA-deficient patients with antibodies against IgA and a history of IgA hypersensitivity, as it contains trace amounts of IgA (40 mcg/mL). • Isolated vaccinia keratitis. • History of anaphylactic or severe systemic reaction to human globulins. • IgA deficiency with antibodies against IgA and a history of IgA hypersensitivity

Boxed warning (interactions with glucose monitoring systems): Blood glucose measurement in patients receiving VIGIV must be done with a glucose-specific method (monitor and test strips) to avoid interference by maltose contained in VIGIV. • Hypersensitivity to human immune globulin (acute anaphylaxis). • Acute renal dysfunction/failure. • Thrombosis may occur with immune globulin products, including VIGIV. For patients at risk of thrombosis, administer VIGIV at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity. • Hemolysis or hemolytic anemia. • Aseptic meningitis syndrome (AMS). • Noncardiogenic pulmonary edema [Transfusion-Related Acute Lung Injury (TRALI)]. • Transmission of infectious agents from human plasma.

The adverse drug reactions to VIGIV treatment in clinical trials (>10%) include headache, nausea, rigors and dizziness.

• Efficacy of live attenuated virus vaccines may be impaired by immune globulin administration, revaccination may be necessary. • Antibodies in VIGIV may interfere with some serological tests

Product is stored frozen at or below -15°C (≤5°F). Use within 60 days of thawing at 2°C to 8°C (36°F to 46°F).